American Psychiatric Association Annual Meeting
American Psychiatric Association Annual Meeting
May 16, 2016
2 min read

Vraylar safe, effective in FDA-approved dosages for schizophrenia, bipolar disorder

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ATLANTA — Vraylar was generally safe, well-tolerated and effective in FDA-approved dose ranges among individuals with schizophrenia or bipolar I disorder, according to data presented at the American Psychiatric Association Annual Meeting.

“Cariprazine, a potent dopamine D2/D3 receptor partial agonist, is FDA-approved for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder,” Willie Earley, MD, executive director of clinical development at Allergan, and colleagues wrote. “Efficacy and tolerability of cariprazine in schizophrenia and bipolar disorder were demonstrated in randomized, double-blind, placebo-controlled phase 2/3 clinical trials. A number of these studies utilized a flexible-dose design, and patients received doses outside of the approved dose range.”

To assess safety and tolerability of Vraylar (cariprazine, Actavis Pharma) in modal daily doses within the FDA-approved range of 1.5 mg to 6 mg per day, researchers conducted a pooled post-hoc analysis of four 6-week trials for schizophrenia and three 3-week trials for bipolar disorder. Participants were grouped into pooled dose groups based on modal daily dose. These included participants with schizophrenia who received placebo (n = 584), 1.5 mg to 3 mg of cariprazine per day (n = 539) or 4.5 mg to 6 mg of cariprazine per day (n = 575), and those with bipolar disorder who received placebo (n = 442) or 3 mg to 6 mg of cariprazine per day (n = 263).

In three of the four trials among individuals with schizophrenia, cariprazine significantly improved Positive and Negative Syndrome Scale total scores (P < .01) in all studies, compared with placebo.

In all three trials among individuals with bipolar disorder, cariprazine significantly improved Young Mania Rating Scale total scores compared with placebo (P < .001).

Discontinuation due to adverse events occurred in 12% of participants with schizophrenia who received placebo, 10% of those with schizophrenia who received cariprazine, 7% of those with bipolar disorder who received placebo and 11% of those with bipolar disorder who received cariprazine.

Akathisia was the most commonly reported treatment-emergent adverse event in both indications.

Additional commonly reported treatment-emergent adverse events included extrapyramidal disorder, tremor, restlessness and vomiting.

Gary Sachs, MD

Gary Sachs

Incidence of serious adverse events were similar for cariprazine and placebo.

Mean changes in body weight were small for all dose groups and indications.

Mean changes in metabolic parameters were similar between treatment groups, except for greater glucose and triglyceride increases among participants with bipolar disorder.

Mean prolactin levels decreased in both among all participants.

“There are significant unmet needs in the treatment of mental illness. Schizophrenia and bipolar I disorder are among the most complex and challenging psychiatric disorders to manage because patients with bipolar I disorder and schizophrenia can differ significantly in terms of their symptoms, disease course, severity and response to treatment,” Gary Sachs, MD, of Massachusetts General Hospital and Harvard Medical School, told “However, currently there are only three medicines that are FDA-approved as first-line monotherapy for bipolar depression. Similarly, the negative symptoms of schizophrenia are often debilitating and significantly impact a person’s ability to function. The variability in how these illnesses manifest and in individual response to treatment makes it important for doctors to have a variety of therapeutic options to consider as part of our clinical decision making.” – by Amanda Oldt


Earley W, et al. Safety and efficacy of cariprazine in FDA-approved dose ranges for schizophrenia and bipolar I disorder: a pooled post-hoc analysis. Presented at: American Psychiatric Association Annual Meeting; May 14-18, 2016; Atlanta.

Disclosure: The study was supported by Forest Pharmaceuticals.